The first or second question anyone asks during a social event, or on the sidelines of a middle school soccer game, is what I do for a living. After I give my well-rehearsed elevator speech of the importance of drug or device reimbursement, the person speaking with me always agrees that it’s extremely important. We know it’s important and integral to the commercial success of a drug or device. I wonder why people within the industry who agree that market access and reimbursement are important, do not latch on to this concept early in the development process. After all, in bringing a product to commercialization, companies, acquiring entities, and users know that the product must be paid to be viable. When a company looks at market access and reimbursement early in the process it mitigates downstream risk. Such risks include lost months of payer evaluations, potential denials, and refusal of providers to prescribe the product.
Of course, there is a big difference between a chat over a drink or on the sideline and in-depth planning to bring a molecule or mechanism to market. There is one big thing and a few smaller things to keep in mind. The big thing: somebody needs to pay for the product. Whether the payer is an insurer or a consumer (or both), they need to understand the value of the product they are considering purchasing.
Following this big concept comes the “w” questions: who, what, where, when, and why. Answering these questions, even in a preliminary fashion, will help reduce future obstacles.
Determining Who will pay and use the product helps create an understanding of the reimbursement pathway.
What will be paid for is not so simple; sometimes it’s not only the product, but procedures and other items or services. Figuring out how all that rolls into one payment may be a challenge.
Where is less about geography and more about setting of care. Determining where the patient is treated, or takes a medication, or uses a device, will have significant influence over how the product is paid.
When can be thought of as how often a medication or device is needed. Determining whether there will be utilization limits or dosing cut-offs are an important piece of the reimbursement picture.
Why the patient needs the product has everything to do with how the product is covered by insurance (or an employer). Ensuring that the story behind the product is solid helps pave the way for smoother reimbursement.
These are the tip of the iceberg and illustrate the importance of thinking early in the process about how products will be paid. Contact me at email@example.com to discuss your situation and how market access and reimbursement could fit into your strategic planning.